Variety of biotechs seek capital from public markets after data readouts

Biotechs left and right announced stock sales this week after data drops at ASCO, the European Hematology Association’s annual meeting and elsewhere.

The famed genome editing biotech Editas Medicine seeks about $125 million. Zentalis Pharmaceuticals wants double that. Verastem Oncology eyes $85 million. The tally for Praxis Precision Medicines is $59.1 million. And over at Clene, the figure is $40 million.

The offering at Editas comes after the biotech shared early data on its gene-edited cell therapy EDIT-301, which is being investigated in patients with sickle cell disease and transfusion-dependent beta thalassemia. TD Cowen analyst Phil Nadeau said they were “encouraged by the compelling SCD data and initial data in thalassemia” and will look for longer follow-up later this year to get more insight on how it compares to genomic therapies.

Stifel analysts took a stronger approach, though, asking how it would compare to CRISPR Therapeutics and Vertex’s exa-cel, which could become the first CRISPR therapy to secure FDA approval in December.

“Even for the more recently treated subjects (patients 3-4), early trends mirror those of patients 1-2 suggestive of more favorable outcomes as more patients receive EDIT-301,” Stifel’s Dae Gon Ha wrote on June 11. “That said, with CTX001’s BLA accepted and under review at the FDA (PDUFA: Dec 8 for SCD), how another ex vivo CRISPR/Cas9 mechanism approach can effectively compete in a fairly narrow addressable population – without a meaningful differentiation – is a hard-to-ignore question.”

Meanwhile, New York and San Diego biotech Zentalis is making the financing move after sharing data on its Phase Ib ovarian cancer drug candidate azenosertib. Post-ASCO, TD Cowen analysts wrote in a note that Zentalis is “firing on all cylinders to advance” the WEE1 inhibitor as a monotherapy in multiple Phase II trials. The fall 2022 accelerated approval of ImmunoGen’s Elahere “sets a precedent for the class moving forward, and azeno’s early results suggest that this is achievable,” the analysts wrote on June 8.

The financing will bankroll Zentalis’ work for a few quarters longer than prior projections, going from the second quarter of 2025 to new guidance of “into 2026.”

Verastem’s offering follows ASCO data on its ovarian cancer drug avutometinib, when given alone and in combination with its other investigational med defactinib. The company plans to use the data as part of an accelerated approval filing and expects to start a randomized confirmatory trial in the second half of this year.

Clene plans to use the proceeds of its offering on clinical trials and “potential future commercialization efforts.” On Thursday, the Salt Lake City-based biotech pointed to biomarker data in a platform trial of its ALS drug candidate, CNM-Au8. They looked at neurofilament light chain levels, the same biomarker Biogen used as the backbone for its accelerated approval for Qalsody in April.

Rob Etherington

With that precedent now set, Clene CEO Rob Etherington said his company is “exploring the possibility for a NDA filing.” The program, which uses gold nanocrystals, did not clear a mid-stage test last fall.

“In addition to planning the global Phase 3 ALS trial, we are preparing the complete CNM-Au8 clinical data package including our strong safety evidence, biomarker, survival, and time-to-event analyses for FDA regulatory discussion in the third quarter,” he added in a statement.

And Praxis’ call to investors comes a few days after saying it will enter Phase III by year’s end for ulixacaltamide in essential tremors. It cleared a Phase IIa last year but did not pass the bar in a Phase IIb readout in March. However, Jefferies analyst Kambiz Yazdi wrote earlier this month that they think the drug candidate “showed clear activity in ET and Praxis can forge a path forward.”

“There is a lot of white space for a new drug in ET since none have been approved since 1967,” Yazdi wrote.

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